SADDLE BROOK, N.J. & AACHEN, Germany–(BUSINESS WIRE)–CircuLite®, Inc. today announced that updated clinical data
related to the Synergy® miniature ventricular support system was presented
in two oral presentations and one poster session at the International Society for Heart and Lung Transplantations 32nd
Annual Meeting and Scientific Sessions (ISHLT) in Prague, Czech Republic.
The Company also announced the successful implantation of the Synergy system in
its 51st patient in the ongoing CE Mark trial.

Updated results presented from the ongoing CE Mark clinical
trial for the Synergy system included significant improvements in hemodynamics,
exercise capacity and quality of life in INTERMACS 4, 5 and 6 heart failure
patients. A second presentation described the induction of positive physical
changes to the left ventricle with the Synergy system, including size
reductions toward normalcy (reverse remodeling). These data came from a study
conducted in a preclinical model of heart failure and from a comparative
analysis of explanted hearts conducted at the time of heart transplantation. A
poster presentation discussed preclinical data supporting the feasibility of
bi-ventricular support with two Synergy pumps.

“Approximately 90 percent of the patients in the ongoing CE
Mark trial were classified as INTERMACS 4, 5 and 6. The risk of currently
marketed cardiac support device implantation could be considered too high for
many in this group, yet these patients are very sick and their quality of life
is severely impacted,” said Bart Meyns, M.D., Ph.D., Professor and Chief of
Cardiac Surgery at Gasthuisberg
University Hospital
and clinical advisor to CircuLite. “The Synergy System is implanted in an
off-bypass procedure and results from early clinical experience for this
first-of-its-kind technology are encouraging and support the potential for
Synergy to treat a larger proportion of heart failure patients who are not
responding to standard medical care and are not candidates or eligible for
heart transplantation.”

“CircuLite is establishing its leadership position in
developing less invasive circulatory assist systems with the worlds smallest
implantable blood pump technology for long-term use,” said Paul Southworth,
President and Chief Executive Officer of CircuLite. “Surpassing the 50th
patient milestone in our ongoing CE Mark trial demonstrates that CircuLite is
making strong clinical progress with Synergy as we plan to advance the system
with CE Mark in the coming months, initiate a U.S. pilot trial with Synergy and
continue to advance our strong pipeline of next-generation circulatory support
systems.”

CircuLites Synergy system includes a micro-blood pump the
size of a AA battery that can be implanted superficially in a
“pacemaker-like” pocket. Synergy is the first and smallest surgically
implanted device designed for partial circulatory support (up to 4.25L/min) in
patients with heart failure. CircuLite is currently conducting a clinical trial
with Synergy in patients with Class IIIB/early Class IV heart failure at
multiple centers in Europe, aimed at achieving
CE Mark.

In an oral session, Professor Meyns presented an abstract
titled “A New Treatment Option for INTERMACS Profile 4, 5 and 6 Patients with
the Circulite® Synergy® System” by B. Meyns, F. Rega, M. Strueber, A. Barbone,
E. Vitali and D. Burkhoff, which detailed an ongoing European study of patients
receiving Synergy system support (data presented on 50 patients). In patients
who underwent follow-up right heart catheterization at a median of 13 weeks
(n=28), cardiac index increased from 2.2 ± 0.5 L/min/M2 to 2.7 ± 0.5 L/min/M2
(p<0.001) and large reductions in capillary wedge pressure from 27.1 ± 9.6
mmHg to 17.5 ± 6.2 mmHg (p<0.001) were observed. In addition, with the
current data available from the ongoing trial, significant increases in
exercise tolerance, functional status and quality of life were observed.
Improvements made in the Synergy system used in the last 13 patients have
significantly decreased the rate of overall severe adverse events (events per
patient-years). No strokes or other episodes of neurologic dysfunction were
reported in these last 13 patients. These data support the notion that the
Synergy system may provide clinical benefits and, in clinical experience
to-date, has a low adverse event profile that helps justify treating this less
sick patient population.

Another abstract titled “Reverse Remodeling With the Use of
the CircuLite® Synergy® Circulatory Assist System” by J. Geens, P. Claus, S.
Jacobs, M. Martin, I. Van Tichelen, F. Rega, D. Burkhoff and B. Meyns was
presented in an oral session by Professor Meyns. The team examined preclinical
models of chronic heart failure as well as 37 hearts at the time of explants in
patients undergoing heart transplantation (19 without cardiac support, 13
supported by HeartMate II and 5 by Synergy). Across both preclinical and
clinical analyses, six weeks of partial ventricular unloading with the Synergy
system induced remodeling of the left ventricle. Hearts supported by the
Synergy system had significantly lower volumes and geometric distortion than
those of chronically failing unsupported hearts, as well as normalization of
passive end-diastolic pressure-volume relationships. These data were also
reflected in the clinical trial data, in which patients cardiac indices
increased over the duration of support, suggesting that reverse remodeling did
occur. Additionally, one patient experienced myocardial recovery after 140 days
support; the Synergy micro-pump was explanted and the patient is doing well.

A poster titled “Two CircuLite Pumps as Bi-Ventricular
Assist Device (BVAD) in an Ovine Animal Model” by J.D. Schmitto, D. Burkhoff,
M. Avsar, O. Fey, P. Ziehme, G. Buechler, A. Haverich and M. Strueber was also
presented. Bi-ventricular support (simultaneous support of the left and right
ventricles) with two Synergy system micro-pumps was proven to be feasible and
able to provide full hemodynamic support in a preclinical model. This approach
holds promise for providing bi-ventricular partial support in humans and, in
particular, for full support in small adults and children.

About Synergy®

Synergy is a miniature ventricular support system that offers the potential of
a new minimally invasive treatment option for patients with chronic heart failure
who are not responding to standard medical care. The systems less invasive
implant procedure is intended to reduce the surgical risks associated with
implant procedures that require cardiopulmonary bypass support. In addition,
Synergy is intended to reduce symptoms of heart failure and associated
re-hospitalizations, as well as to improve exercise tolerance and quality of
life.

Synergy’s micro-pump is the size of a AA battery, circulates
up to 4.25 liters of blood per minute, and is intended to reduce the heart’s
workload while improving blood flow to vital organs. Synergy supplements the
heart’s native pumping capacity and preserves its ability to respond to the
patient’s cardiac output demands. The system is surgically implanted using a
mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket.

About CircuLite®

CircuLite is developing disruptive solutions to improve the treatment of
chronic heart failure. The Companys minimally invasive circulatory support
systems are intended to work in conjunction with the heart to enhance clinical
outcomes and improve quality of life for patients and their families. Synergy®,
currently in a CE Mark clinical trial, features the worlds smallest surgically
implanted blood pump for long-term use in patients diagnosed with heart
failure. Next-generation circulatory support systems in development that
incorporate CircuLite’s micro-pump technology include an endovascular system, a
right-heart system, a pediatric system, and an all-support system. For more
information, visit our website at www.circulite.net.